A. The Importance of Sterility in Dialysis Connections
Typical medical connectors used widely in modern medical practices are connectors for solution containers, administration sets and catheters. Sterile medical solutions such as for intraveneous feeding, transfusions, peritoneal dialysis and the like, are frequently administered to patients through a fluid conduit, a portion of which may be surgically implanted in the body. Medical procedures require a connection where the bacterial population is minimized because in such cases, an in-dwelling conduit, such as a sterile cannula, having one end located within the body has the other or second end remaining outside the body for connection to fluid administration conduit tubing. The medical solutions are commercially available packaged in containers such as flexible plastic bags or glass bottles and separate sterile, plastic disposable administration tubing is used to pass the contents of such bags through the in-dwelling conduit into the patient's body. Likewise, such separate sterile plastic disposable administration tubing sets are utilized for expelling body fluids and/or recirculating body fluids after toxin removal. The bag, administration tubing and in-dwelling conduit must form a sterile fluid circuit. Therefore, it is essential that any connection between the conduit circuit elements must be established and maintained in an antiseptic condition to avoid contamination.
Medical, biological, pharmaceutical research and medical care most frequently require that not any bacterium or other infectious agents such as yeast, fungus, virus and the like and minimum disinfection liquids penetrate into a system of mutually connected units such as tubings, bottles, containers, catheters and infusion means as well as drains.
Of particular importance in the medical care area is in the treatment of patients experiencing partial or total kidney failure. The most widely used method of kidney dialysis for treatment of kidney failure i.e. renal disease is hemodialysis. In hemodialysis the patient's blood is cleansed by passing the blood through an artificial kidney and a kidney dialysis machine. By the process of diffusion across the semipermeable membrane in the artificial kidney, impurities and toxins are removed from the patient's blood to thereby perform a function of the patient's natural kidneys. Hemodialysis is required several times a week, each dialysis requiring several hours in a dialysis center wherein the patient is tied to the machine through arterial blood lines which convey the blood to and from the kidney machine.
Another treatment of renal disease is through a procedure known as intermittent peritoneal dialysis. In this procedure, a dialysis solution is infused into the patient's peritoneal cavity by means of tubing and a catheter. The peritoneum, which defines a peritoneal cavity, contains many small blood vessels and capillary beds which act as a natural semipermeable membrane. The natural membrane may be contrasted with the artificial membrane used in hemodialysis. In both cases, however, impurities and toxins in the blood are removed by diffusion across a membrane such as a cellulose membrane of the artificial kidney or a peritoneal natural membrane of the peritoneal cavity. Dialysis solutions remain in the patient's peritoneal cavity in intermittent peritoneal dialysis for a time sufficient for blood impurities to be removed by diffusion across the peritoneal membrane into the dialysis solution. The impurity containing dialysis solution then is drained from the peritoneal cavity by means of a catheter and tubing and a fresh supply of dialysis solution is infused. Intermittent peritoneal dialysis uses pumps or other auxiliary equipment to which the patient is again generally tied during dialysis, i.e. the patient must remain sedentary.